May 2026 FDA Recall Drug by Haleon Us Holdings Llc
D-0542-2026 - Labeling

This Class II drug recall was voluntarily initiated by Haleon Us Holdings Llc on May 11, 2026 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0542-2026

Reason for Recall
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Initiated
05-11-2026
Reported
05-27-2026
Quantity
285,330 blister cards

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98910
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Haleon US Holdings LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the product.
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Batch or Lot Expiration Information

Lot# Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.